FDA Adverse Event
Malfunction
Summary report: N
TELEVIX 1600
MDR report key: 1191105
·
Received September 26, 2008
Report
- Report Number
- 2126677-2008-00074
- Event Type
- Malfunction
- Date Received
- September 26, 2008
- Date of Event
- June 23, 2008
- Report Date
- June 23, 2008
- Manufacturer
- GE MEDICAL SYSTEMS, LLC.
- Product Code
- KXJ
- PMA / PMN Number
- K790692
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE FIELD ENGINEER (FE) FOUND THAT DIRT HAD JAMMED THE JOYSTICK CAUSING THE UNINTENDED MOTION. THE FE REPAIRED THE SYSTEM BY REPLACING THE AFFECTED JOYSTICK.
Description of Event or Problem · 1
IT WAS REPORTED THAT A TELEVIX 1600 TUBE ARM MOVED TOWARDS THE FOOT END OF THE TABLE WITHOUT COMMAND FROM THE OPERATOR. NO INJURY WAS REPORTED. DIRT WAS FOUND IN THE JOYSTICK, WHICH CAUSED THE JOYSTICK TO BECOME STUCK WHEN THE OPERATOR WAS ACTUATING THE JOYSTICK, CAUSING THE UNINTENDED MOTION. IF THIS WERE TO HAPPEN WHEN THE TABLE IS IN A VERTICAL POSITION AND A PATIENT IS LOCATED ON A STRETCHER UNDERNEATH THE TUBE ALLOWING THE TUBE HEAD TO CONTACT THE PATIENT, A SERIOUS INJURY MAY OCCUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TELEVIX 1600 | KXJ | GE MEDICAL SYSTEMS, LLC. | 11608B | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR |